Endothelial DysfunctionNCT06403241
The Association Between Food Timing and Composition on Gastrointestinal Injury, Stress Hormone and Gastrointestinal Complains.
An observational study of Endothelial Dysfunction, run by Poznan University of Physical Education at 1 site in Poland.
Trial summary
The study aimed to check the influence of timing and composition of diet on markers of gut injury, endotoxemia and stress. Read more about this study
- Who is it for?
- Ages 18 to 23 years, men onlyHealthy volunteers can take part
- Conditions the study is for
- Endothelial Dysfunction
- What is being tested?
- 2000 meter ergometer test
- How many people
- 13 participants
- Where
- 1 sitePoland
- Study dates
- 1 May 2023to 30 Jun 2023
- Phase
- Observational
- Are there results?
- None posted in the registry
Key requirements
Who can take part, as listed by the sponsor. Only the study team can confirm whether you are eligible, so take this list to your doctor.
- Ages 18 to 23 years
- Men only
- Healthy volunteers accepted
- Adult
Study population: Male rowers age 18 - 22 years.
Who may be able to join
- Membership in Polish Rowing Team,
- minimum five years of training,
- total training time minimum of 240 minutes,
- filling out a food diary,
- finishing 2000-meter ergometer test.
Who cannot join
- Probiotics within the last three months,
- prebiotics within the last three months
- antibiotic therapy within the last three months,
- dietary regime,
- gastrointestinal diseases,
- lactose intolerance
Trial locations and contacts
1 site in 1 country.
Poland1 site
Poznan University of Physical Education, Faculty of Sport Sciences in Gorzow
Gorzów Wielkopolski, Lubusz Voivodeship, 66-400
About this study
Official title: The Association Between Food Timing and Composition on Gastrointestinal Injury, Stress Hormone and Gastrointestinal Complains in Elite Rowers After 2000m Ergometer Test - an Observational Study.
The study aimed to check the influence of timing and composition of diet on markers of gut injury, endotoxemia and stress.
Read the detailed description
The research protocol includes detailed food intake analysis, including timing and composition, markers related to the neuroendocrine pathway cortisol, and observations of individually experienced symptoms. Moreover, the study also explores intestinal injury and endotoxemia parameters, such as I-FABP, CLDN-3, and LBP. As a first goal, this study investigates the timing and composition of food intake concerning changes in gut integrity, cortisol levels, and gastrointestinal symptoms. Investigators explored whether an athlete's nutritional intake influences any GI disturbance induced by high-intensity exercise. As a second goal, Investigators tried to connect symptoms and markers from both pathways with gastrointestinal complaints. Investigators hypothesised that cortisol levels would be more profound than other studied parameters in gastrointestinal symptoms.
- Conditions
- Endothelial Dysfunction
- Being tested
- 2000 meter ergometer test
- Keywords
- athlete's diet, endotoxemia, cortisol, gut injury, gut permeability, exercise
- Medical subject headings
- Endotoxemia, Motor Activity
What participants receive
What participants receive. In a randomised study each person is assigned to one group by chance.
2000 meter ergometer testOther
Rowers performed 2000m ergometer test.A 2,000-m time trial is a standard test used to assess performance in rowers.
What is being measured
The primary outcome is the main question the study is designed to answer.
I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury
I-FABP concentration measured in blood [ng/ml] using commercially available enzyme-linked immunosorbent assays
Measured: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period
Claudin to measure tight junction leakage
Zonulin concentration measured in blood [ng/ml] using commercially available enzyme-linked immunosorbent assays
Measured: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period
LBP (lipopolysaccharide binding protein) to measure endotoxin
LBP concentration measured in blood [ug/ml] using commercially available enzyme-linked immunosorbent assays
Measured: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period
Lactic acid to measure fatigue after the race
Lactate concentration measured in capillary blood from earlobe [mmol/L] using a commercially available kit (Diaglobal, Berlin, Germany)
Measured: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test
Corisol
Stress hormoneconcentration measured in blood [ng/ml] using commercially available enzyme-linked immunosorbent assays
Measured: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period
Secondary outcomes (15)
energy
energy [kcal ]of food intake measured by food diary
Measured: whole day (24hours) before test, in the morning before the test
protein
protein [g ]of food intake measured by food diary
Measured: whole day (24hours) before test, in the morning before the test
fat
fat [g ]of food intake measured by food diary
Measured: whole day (24hours) before test, in the morning before the test
carbohydrate
carbohydrate [g ]of food intake measured by food diary
Measured: whole day (24hours) before test, in the morning before the test
glucose
glucose [g ]of food intake measured by food diary
Measured: whole day (24hours) before test, in the morning before the test
lactose
lactose [g ]of food intake measured by food diary
Measured: whole day(24hours) before test, in the morning before the test
saccharose
saccharose [g ]of food intake measured by food diary
Measured: whole day (24hours) before test, in the morning before the test
fructose
fructose [g ]of food intake measured by food diary
Measured: whole day (24hours) before test, in the morning before the test
fiber
fiber [g ]of food intake measured by food diary
Measured: whole day (24hours) before test, in the morning before the test
Body mass
Body mass [kg] measured by electronic scale to the nearest 0,05 kg (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
Measured: in the morning before the test up to 1 hour after getting up
Body fat
Body fat [%] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
Measured: in the morning before the test up to 1 hour after getting up
Total body water
Body fat [%] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
Measured: in the morning before the test up to 1 hour after getting up
Lean body mass
Lean body mass [kg] measured by electronic scale (Tanita BC 418 MA Tanita Corporation, Tokyo, Japan).
Measured: in the morning before the test up to 1 hour after getting up
height
[cm] measured by high meter
Measured: in the morning before the test up to 1 hour after getting up
self reported gastrointestinal scale
10 point scale
Measured: up to 1 hours after the test
Timeline
From the start of the study to its completion; the mark is today. Estimated dates are the sponsor’s plan.
- First posted7 May 2024
- Study start1 May 2023
- Primary completion1 Jun 2023
- Study completion30 Jun 2023
Resources
- Official record on ClinicalTrials.govThe registry entry this page is built from, with its full change history.
- Other trials for Endothelial DysfunctionStudies of the same condition, open and under way.
- What the trial phases meanHow a treatment moves from first tests in people to approval.
More details
For doctors and researchers: how the study is designed, who runs it, and its registry IDs.
Study design
- Study type
- Observational
- Observational model
- Cohort
- Time perspective
- Retrospective
- Enrolment
- 13 participants (actual)
Sponsor and investigators
- Lead sponsor
- Poznan University of Physical Education
- Sponsor type
- University, hospital or other
- Responsible party
- Sponsor
- Investigators
- Anna Skarpańska-Stejnborn, professor, Study director, Poznan University of Physical Education
IDs, dates and publications
- ClinicalTrials.gov ID
- NCT06403241
- Sponsor's protocol ID
- Rowerscometetive2023
- Status last verified
- Jun 2023
- First submitted
- 26 Apr 2024
- Last updated
- 7 May 2024
- Results posted
- No
- Data monitoring committee
- No
- FDA-regulated drug
- No
- FDA-regulated device
- No
Study at a glance
From the registry record, last updated by the sponsor on 7 May 2024. Recruitment status is as the sponsor reported it: confirm with the study team.
- Official title
- The Association Between Food Timing and Composition on Gastrointestinal Injury, Stress Hormone and Gastrointestinal Complains in Elite Rowers After 2000m Ergometer Test - an Observational Study.
- ClinicalTrials.gov ID
- NCT06403241
- Acronym / sponsor ID
- Rowerscometetive2023
- Conditions
- Endothelial Dysfunction
- Keywords
- athlete's diet, endotoxemia, cortisol, gut injury, gut permeability, exercise
- Study type
- Observational
- Recruitment status
- Completed
- Enrolment
- 13 participants (actual)
- Lead sponsor
- Poznan University of Physical EducationUniversity, hospital or other
- Study start
- 1 May 2023 (actual)
- Primary completion
- 1 Jun 2023 (actual)
- Study completion
- 30 Jun 2023 (actual)
- First posted
- 7 May 2024 (actual)
- Results
- Not posted in the source record
Clinical summary
The research question as the sponsor registered it. This describes what the study plans to test, not what it found.
The study aimed to check the influence of timing and composition of diet on markers of gut injury, endotoxemia and stress.
Detailed description
The research protocol includes detailed food intake analysis, including timing and composition, markers related to the neuroendocrine pathway cortisol, and observations of individually experienced symptoms. Moreover, the study also explores intestinal injury and endotoxemia parameters, such as I-FABP, CLDN-3, and LBP. As a first goal, this study investigates the timing and composition of food intake concerning changes in gut integrity, cortisol levels, and gastrointestinal symptoms. Investigators explored whether an athlete's nutritional intake influences any GI disturbance induced by high-intensity exercise. As a second goal, Investigators tried to connect symptoms and markers from both pathways with gastrointestinal complaints. Investigators hypothesised that cortisol levels would be more profound than other studied parameters in gastrointestinal symptoms.
Study design
- Observational model
- Cohort
- Time perspective
- Retrospective
Who may qualify
- Ages
- 18 to 23 years
- Sex
- Male only
- Healthy volunteers
- Accepted
- Age groups
- Adult
- Study population
- Male rowers age 18 - 22 years.
Key inclusion criteria (5 listed)
- Membership in Polish Rowing Team,
- minimum five years of training,
- total training time minimum of 240 minutes,
- filling out a food diary,
- finishing 2000-meter ergometer test.
Key exclusion criteria (6 listed)
- Probiotics within the last three months,
- prebiotics within the last three months
- antibiotic therapy within the last three months,
- dietary regime,
- gastrointestinal diseases,
Eligibility is decided by the study team after screening; this overview does not establish that a patient qualifies. Full inclusion and exclusion criteria.
Interventions
| Intervention | Type | Arms |
|---|---|---|
| 2000 meter ergometer testRowers performed 2000m ergometer test.A 2,000-m time trial is a standard test used to assess performance in rowers. | Other | – |
Primary outcome
I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury
Time frame: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period
I-FABP concentration measured in blood [ng/ml] using commercially available enzyme-linked immunosorbent assays
Claudin to measure tight junction leakage
Time frame: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period
Zonulin concentration measured in blood [ng/ml] using commercially available enzyme-linked immunosorbent assays
LBP (lipopolysaccharide binding protein) to measure endotoxin
Time frame: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period
LBP concentration measured in blood [ug/ml] using commercially available enzyme-linked immunosorbent assays
Lactic acid to measure fatigue after the race
Time frame: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test
Lactate concentration measured in capillary blood from earlobe [mmol/L] using a commercially available kit (Diaglobal, Berlin, Germany)
Corisol
Time frame: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period
Stress hormoneconcentration measured in blood [ng/ml] using commercially available enzyme-linked immunosorbent assays
15 secondary outcomes
energy
Time frame: whole day (24hours) before test, in the morning before the test
protein
Time frame: whole day (24hours) before test, in the morning before the test
fat
Time frame: whole day (24hours) before test, in the morning before the test
carbohydrate
Time frame: whole day (24hours) before test, in the morning before the test
glucose
Time frame: whole day (24hours) before test, in the morning before the test
lactose
Time frame: whole day(24hours) before test, in the morning before the test
saccharose
Time frame: whole day (24hours) before test, in the morning before the test
fructose
Time frame: whole day (24hours) before test, in the morning before the test
fiber
Time frame: whole day (24hours) before test, in the morning before the test
Body mass
Time frame: in the morning before the test up to 1 hour after getting up
Body fat
Time frame: in the morning before the test up to 1 hour after getting up
Total body water
Time frame: in the morning before the test up to 1 hour after getting up
Lean body mass
Time frame: in the morning before the test up to 1 hour after getting up
height
Time frame: in the morning before the test up to 1 hour after getting up
self reported gastrointestinal scale
Time frame: up to 1 hours after the test
Results and safety
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
Research links
- Official record on ClinicalTrials.govLast updated by the sponsor 7 May 2024.
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Referral and contact
AzTrials does not enrol participants or take referrals. Contact the study team or a site listed below; they decide who can take part. This study is not recruiting at the moment.
Anna Skarpańska-Stejnborn, professor study director
Poznan University of Physical Education
1 site in 1 country: see every site and its status.
Questions about this trial
What is this clinical trial studying?
An observational study of Endothelial Dysfunction, run by Poznan University of Physical Education at 1 site in Poland.
The full registered description is in the About this study section and the official record.
Who may be eligible to take part?
The sponsor lists 5 inclusion and 6 exclusion criteria. Eligibility is decided by the study team after screening, so read the full criteria and contact a listed site.
Is this clinical trial currently recruiting?
The record says: finished, as of the sponsor's last update on 7 May 2024. Status can change between updates, so confirm with the study contact before making plans.
Where is the study taking place?
The record lists 1 site in Poland. Whether a site is taking part right now should be confirmed with that site. See every site.
What are the possible benefits and risks?
They depend on the study and the treatment, and no study can promise a benefit. The study team explains the known risks during informed consent, before anyone joins; the record itself does not list them.
Are results available for this study?
The study is completed, but results are not available in the source record. That does not mean the treatment did or did not work.
How can a doctor refer a patient or contact the research team?
The record lists no contact. The official record names the sponsor, who can be asked directly. AzTrials does not enrol participants or take referrals.
What does the primary outcome measure?
I-FABP (intestinal fatty acid binding protein)to measure epithelial wall injury (time frame: Blood samples was taken from the cubital vein at three-time points: before each stress test (after overnight fasting) up to one hour after getting up, 1 minute after the test, and 1-hour recovery period). The study lists 5 primary outcomes in all. It is what the study was designed to measure, not a finding.
Where can I read the original study information?
Does a listing mean the treatment is approved or proven to work?
No. A listing means the study is registered. It does not show that the treatment is safe, works, or is approved by a regulator.
How often is this information updated?
AzTrials copies changed records from ClinicalTrials.gov every night and reloads the whole registry every week. The sponsor last updated this record on 7 May 2024.